Femoral Preincisional Block in Acute Postoperative Pain M... | NCT02239497

Studies
Femoral Preincisional Block in Acute Postoperative Pain Management of Surgery Orthopaedic Lower Limb

NCT02239497

Sponsor

Hospital Central Dr. Luis Ortega

Status

Completed

Last Update Posted

Sep 12, 2014Estimated

Enrollment

30Actual

Phase

Phase 4

Conditions

Surgery

Interventions

Femoral block by ultrasound and neurostimulation
Intravenous analgesia

Countries

Venezuela

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

Sep 2013Actual

Completion Date

Not provided

First Submitted Date

Sep 7, 2014

First Submission Date that Met QC Criteria

Sep 10, 2014

First Posted Date

Sep 12, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 10, 2014

Last Update Posted Date

Sep 12, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Beatriz Arismendi Gómez, Anesthesiologist, Hospital Central Dr. Luis OrtegaPrincipal Investigator

Lead Sponsor

Hospital Central Dr. Luis OrtegaOTHER

Collaborators

Not provided

Description Module

Brief Summary

Proper management of acute postoperative pain (DAPO) is essential for the recovery of orthopedic surgeries. The blockade of the femoral nerve preincisional (BFP) is simple and its effectiveness increases guided by ultrasound and neurostimulation. OBJECTIVE: To evaluate the effectiveness of BFP in patients undergoing orthopedic surgery of the lower limbs under general anesthesia. METHODS: A comparative study was conducted, randomized, two groups, surgeries of the hip, femur and knee, ASA I-II, aged 18 years. Group B (n = 15) received BFP and ultrasound-guided nerve stimulation with 20 ml of bupivacaine 0.5% plus epinephrine 1: 200,000. Group S (n = 15) without blocking. Both groups received intravenous analgesia with ketoprofen 100 mg regimen and dipyrone 1g c / 8 hs and balanced general anesthesia. Postoperative morphine 0.03 mgr / kgr / weight was administered if EVA ≥4

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
femoral block by US and NE and intravenous analgesia	Experimental	preincisional femoral block by ultrasound and neurostimulation, with 20 ml bupivacaine 0,5% and epinephrine. ketoprofen, dipyrone and dexamethasone IV. Morphine IV to rescue analgesia	Procedure: Femoral block by ultrasound and neurostimulation Drug: Intravenous analgesia
Intravenous analgesia	Experimental	Intravenous analgesia with ketoprofen, dipyrone and morphine. IV morphine to rescue analgesia	Drug: Intravenous analgesia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Femoral block by ultrasound and neurostimulation	Procedure		femoral block by US and NE and intravenous analgesia
Intravenous analgesia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperatory EVA values and need for rescue analgesia with IV morphine		24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA I and II patients, both sexes, plan for elective orthopaedic surgery of the lower limbs (femur and knee) under general anesthesia

Exclusion Criteria:

Patients with any anesthetic or surgical complication
Patients with neuromuscular diseases
Allergy to any of the drugs used in the study
Inability to understand and use a pain scale
Also those patients in whom it was not possible to locate anatomical landmarks and / or failed femoral block

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Beatriz S Arismendi Gomez, MD	Hospital "Dr Luis Ortega"	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Servicio de Anestesiologia Hospital "Dr. Luis Ortega"		Porlamar	Nueva Esparta	6301	Venezuela